FDA approves new indication for drug to treat NDO in pediatric patients

FDA approved on Thursday a new indication for mirabegron extended-release tablets (Myrbetriq—Astellas Pharma US) and mirabegron for extended-release oral suspension (Myrbetriq Granules—Astellas Pharma US) to treat neurogenic detrusor overactivity (NDO) in children aged 3 years and older. Mirabegron extended-release tablets are also indicated for overactive bladder in adults. NDO is a dysfunction of the bladder that results from congenital conditions, such as spina bifida, or other disease or injury in the nervous system, such as spinal cord injury. “Today’s action is a positive step for the treatment of NDO in young patients,” said Christine P. Nguyen, MD, director, FDA’s Division of Urology, Obstetrics and Gynecology, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research. “Mirabegron, the active ingredient in Myrbetriq and Myrbetriq Granules, works by a different mechanism of action from the currently approved treatments, providing a new treatment option for these young patients.” The most common adverse effects with Myrbetriq and Myrbetriq Granules with NDO were urinary tract infection, nasopharyngitis, constipation, and headache. The two products may increase blood pressure and may make blood pressure worse in patients with a history of high blood pressure, and they may also cause angioedema. Myrbetriq and Myrbetriq Granules are two different products and are not substitutable on a milligram-per-milligram basis. A recommended dosage for Myrbetriq Granules for adults has not been determined.